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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05263232
Other study ID # NL77984.068.21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 16, 2022
Est. completion date April 18, 2023

Study information

Verified date August 2023
Source Maastricht University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will investigate the potential benefit of scheduled natural daylight exposure to improve glucose control in type 2 diabetes (T2D) patients and to unravel molecular mechanisms underlying the effects of natural daylight on circadian clocks and (glucose) metabolism in human skeletal muscle from T2D patients. Participants will stay at our research facilities and will be exposed to natural daylight or artificial light during the daytime over 4.5 days in a randomized cross-over design. For both conditions, the evening and night will be spent under standardized dim and dark conditions.


Description:

Obesity and type 2 diabetes (T2D) are both strongly associated with a westernized lifestyle of low physical activity levels and high caloric intake. However, recently it has been recognized that also our 24-hour culture, characterized by working and eating late, reduced sleep (quantity and quality), and excessive light exposure in the evening and at night, should be considered as lifestyle factors that may negatively impact metabolic health. In this context, a factor that is often overlooked and underestimated is the lack of natural daylight since most people spend almost their entire work time in indoor office environments with limited access to natural daylight through windows. Therefore, this study investigates the potential benefit of scheduled natural daylight exposure to improve glucose control in T2D individuals and to unravel molecular mechanisms underlying effects of natural daylight on circadian clocks and (glucose) metabolism in human skeletal muscle from T2D patients. For this purpose, overweight to obese T2D patients (male and female) will undergo a randomized cross-over trial in which each subject serves as its own control. Participants will stay at our research facilities and will be exposed to natural daylight or artificial light during the daytime over 4.5 days. For both conditions, the evening and night will be spent under standardized dim and dark conditions, respectively. Over these two 4.5 days intervention periods, extensive 24h metabolic profiling will be conducted, including 24h continuous glucose monitoring, 24h blood and saliva sampling, 24h blood pressure and heart rate assessments, 24h core and skin temperature assessments, 24h energy expenditure and whole-body substrate metabolism, and a skeletal muscle biopsy and a mixed meal tolerance test with indirect calorimetry will be performed on the respectively last test day.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date April 18, 2023
Est. primary completion date November 30, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria: - Participants are able to provide signed and dates written consent prior to any study specific procedures - Male + females (postmenopausal defined as at least 1 year post cessation of menses) - T2DM duration at least 1 year - BMI: = 25 kg/m² - Age: 40-75 - Well-controlled diabetes with respect to glycemic control and on stable anti-diabetes medication regimes - Habitual bedtime of 23:00 ± 2h - Regular sleep duration (7-9 h/night) - Stable dietary habits: no weight gain or loss > 5 kg in the last three months Exclusion Criteria: - Insulin treatment - Uncontrolled hypertension - Signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy - Signs of active liver or kidney malfunction - Use of SGLT2 inhibitors - Using > 400mg caffeine daily (more than 4 coffee or energy drink) - Extreme early bird or extreme night person (score =30 or =70 on MEQ-SA questionnaire) - shift work or travel across more than one time zone in the 3 months before the study - Heavily varying sleep-wake rhythm - Frequent engagement in programmed exercise as judged by the investigator - Any medication that will interfere with the study outcomes or hamper the safety of the participant - Alcohol consumption of >2 servings per day for men and >1 serving per day for woman - Significant food allergies/intolerance (seriously hampering study meals) - Subjects who do not want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed - Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator - Smoking in the past 6 months

Study Design


Intervention

Other:
Natural or artificial office light exposure
Over 4.5 days, participants will stay at our research facilities under different light conditions. Over these days different measurements will take place, including 24h continuous glucose monitoring, 24h blood and saliva sampling, 24h blood pressure and heart rate assessments, 24h core and skin temperature assessments, 24h energy expenditure and whole-body substrate metabolism, and a skeletal muscle biopsy and a mixed meal tolerance test with indirect calorimetry will be performed on the respectively last test day.

Locations

Country Name City State
Netherlands Maastricht University Maastricht

Sponsors (3)

Lead Sponsor Collaborator
Maastricht University University of Geneva, Switzerland, Velux Fonden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other 24 hour energy expenditure Energy expenditure (kJ/min) measured at 8:00, 13:00, 18:00 and 22:30 on Day 4
Other 24h whole-body energy metabolism (cabrohydrate oxidation) Carbohydrate oxidation (µmol/kg x min) measured by indirect calorimetry measured at 8:00, 13:00, 18:00 and 22:30 on Day 4
Other 24h whole-body energy metabolism (fatty acid oxidation) Fatty acid oxidation (µmol/kg x min) measured by indirect calorimetry measured at 8:00, 13:00, 18:00 and 22:30 on Day 4
Other 24h profiles of plasma metabolites (i.e. free fatty acids, triglycerides, insulin) Plasma levels determined from venous blood draws measured on Day 4 at 8:00, 10:00, 12:00, 13:00, 14:00, 16:00, 18:00, 20:00, 22:00, 23:00, and on Day 5 at 00:00, 02:00, 04:00 and 06:00h
Other Mass spectrometry-based 24h serum lipidomics analysis of all lipid species evident in serum measured on Day 4 at 8:00, 12:00, 16:00, 20:00, and on Day 5 at 00:00, 04:00 and 8:00
Other Sleep quality questionnaire (Leeds Sleep Evaluations Questionnaire - LSEQ) LSEQ scores after each of the 4 nights
Other Sleep quality questionnaire (Pittsburgh Sleep Quality Index - PSQI) PSQI scores after each of the 4 nights
Other 24h blood pressure blood pressure (mmHg) measured hourly from 7:00 to 23:00h on Day 4, and every second hour from 0:00 to 6:00 on Day 5
Other 24h heart rate heart rate (bpm) assesses through chest-worn heart rate monitor measured continously over 4.5 days
Other 24h skin temperature skin temperature (°C) assessed via wireless temperature sensors (iButtons) measured continously on Day 3
Other 24h core body temperature Core body temperature measured by an ingested telemetric pill (°C) measured continously on Day 3
Other mRNA in peripheral blood mononuclear cells (PBMC) of markers involved in the molecular clock Quantify mRNA levels by micro array blood samples taken on Day 4 at 8:00, 13:00, 18:00, 23:00, and on Day 5 at 4:00 and 9:00
Primary average 24h blood glucose levels Interstistial glucose levels determined by continuous glucose monitoring continously over 4.5 days
Secondary Postprandial metabolism upon a mixed-meal tolerance test (energy expenditure) Energy expenditure (kJ/min) measured by indirect calorimetry measured at 9:00, 9:30, 10:00, 11:00, 12:00 and 13:00 on Day 5
Secondary Postprandial metabolism upon a mixed-meal tolerance test (carbohydrate oxidation) Carbohydrate oxidation (µmol/kg x min) measured by indirect calorimetry measured at 9:00, 9:30, 10:00, 11:00, 12:00 and 13:00 on Day 5
Secondary Postprandial metabolism upon a mixed-meal tolerance test (fatty acid oxidation) Fatty acid oxidation (µmol/kg x min) measured by indirect calorimetry measured at 9:00, 9:30, 10:00, 11:00, 12:00 and 13:00 on Day 5
Secondary Postprandial plasma metabolites upon a mixed-meal tolerance test (glucose) Plasma glucose levels determined from venous blood draws measured at 9:00, 9:15, 9:30, 9:45, 10:00, 10:30, 11:00, 11:30, 12:00, 13:00 on Day 5
Secondary Postprandial plasma metabolites upon a mixed-meal tolerance test (insulin) Plasma insulin levels determined from venous blood draws measured at 9:00, 9:15, 9:30, 9:45, 10:00, 10:30, 11:00, 11:30, 12:00, 13:00 on Day 5
Secondary Postprandial plasma metabolites upon a mixed-meal tolerance test (free fatty acids) Plasma FFA levels determined from venous blood draws measured at 9:00, 9:15, 9:30, 9:45, 10:00, 10:30, 11:00, 11:30, 12:00, 13:00 on Day 5
Secondary Postprandial plasma metabolites upon a mixed-meal tolerance test (triglycerides) Plasma triglyceride levels determined from venous blood draws measured at 9:00, 9:15, 9:30, 9:45, 10:00, 10:30, 11:00, 11:30, 12:00, 13:00 on Day 5
Secondary Skeletal muscle biopsy outcomes (Circadian transciptome) Quantify DNA by micro-array muscle tissue taken at 7:30h on Day 5
Secondary Culturing human primary myotubes to assess circadian reporter characteristics in vivo culturing of primary myotubes muscle tissue taken at 7:30h on Day 5
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